Associate Director, Immunoassay (Brisbane)

Position Summary:

Provide scientific leadership for the immunoassay function, setting the strategy and technical direction for PK, ADA, neutralizing antibody and biomarker assay development and validation in accordance with applicable regulatory guidance. Act as the scientific authority and owner of data quality and project delivery, lead and develop a team of scientists, expand laboratory capabilities and capacity, and drive business development through scientific leadership of RFP review and client engagement. This is a key role in the succession planning for the site as the group grows.

Key Responsibilities:

·      Set the scientific direction and strategy for immunoassay (PK, ADA, NAb and biomarker) development and validation, defining technical standards, platform choices and the capability roadmap in line with applicable regulatory guidance and client needs

·      Own the scientific quality and delivery of development and validation projects, critically reviewing data and assay performance to ensure methods are fit for purpose and projects meet quality standards, regulatory expectations and client timelines

·      Serve as the scientific authority for complex assay development, validation and sample analysis challenges across methods and platforms, providing expert troubleshooting and hands-on technical input where needed

·      Lead and manage a team of scientists, setting objectives, managing performance, supporting professional development and career progression, and contributing to recruitment and succession planning

·      Build scientific capability by developing and delivering practical and theoretical training in assay development, validation, troubleshooting and data interpretation, and by mentoring scientists as future technical leaders

·      Represent the immunoassay function externally with clients and at scientific meetings.

·      Review and approve methods, validation plans, data and reports, ensuring scientific integrity, data quality and compliance with applicable regulations and SOPs

·      Lead scientific investigations into deviations and assay failures, determining root cause and corrective and preventive actions, and act as the scientific representative for immunoassay during client audits and regulatory inspections

·      Evaluate, select and implement new technologies, platforms and assay approaches to expand immunoassay capabilities and meet evolving client and regulatory needs

·      Partner with site leadership to plan resources, laboratory capacity, workflows and equipment investment, prioritizing workload across projects to meet business and client demand

·      Lead the scientific review of requests for proposals (RFPs), determining feasibility, assay strategy, scope, resources and timelines to deliver scientifically sound, competitive proposals

Drive business growth as the scientific lead in client discussions and bid defense meetings

Required Qualifications:

·      Ph.D. with 7+ years relevant working experience in a CRO bioanalytical lab, with demonstrated scientific expertise in immunoassay (PK, ADA, NAb and biomarker) development and validation

·      Proven experience leading, managing and developing a team of scientists, including performance management and mentoring future technical leaders

·      Expert knowledge and understanding of regulatory requirements and guidance (GLP, GCP, GCLP, 21 CFR Part 11, and current bioanalytical method validation guidance) and their application to assay strategy and study conduct

·      Demonstrated ability to set scientific strategy, make sound technical decisions and take ownership of data quality and project delivery in a regulated environment

·      Experience leading deviation investigations and representing the laboratory scientifically to clients during client audits and regulatory inspections

·      Excellent communication, presentation and client-facing skills, with the ability to influence stakeholders at all levels, collaborate across functions and represent the company externally as a scientific leader